The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs / GMPs / Inspections and Audits

Indian Drugmaker’s Particulate Problems Expand to Recall of Polish Products

March 7, 2014

Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product.

The recall pertains to 10 lots of injectable etomidate potentially containing small black particles in individual 10- and 20-mL vials. The vials also potentially lacked lot numbers and expiration dates, Mylan said. Illegible or missing lot numbers and expiration dates also extend to the products’ outer carton.

All of the affected products bear a label with the logo for Pfizer, which also markets the non-narcotic sedative. Neither Mylan nor Pfizer have received any reports of adverse events associated with the recalled injectables.

The recall is the latest quality headache Mylan has fielded in connection with Agila, the Indian injectable drugmaker it acquired one year ago for $1.6 billion. Agila was warned by the FDA in September following a late-June inspection of the drugmaker’s Bangalore-based specialty formulations facility (SFF). Agency investigators scrutinized gloves that plant employees use during aseptic processes, noting they were marred with “visible holes and flaking” and had been approved by Agila quality personnel.

Agila has five facilities in India, all of which had been FDA approved as of Oct. 31, 2013, Mylan President Rajiv Malik said on a recent conference call with investors. Despite the warning letter handed to Agila’s SFF, the Indian unit does not face systemic quality issues, he added.

“Agila’s facilities, like any other Mylan facility, will be held to Mylan’s one global quality standard,” spokeswoman Nina Devlin emphasized Feb. 20.

Agila thus far has avoided being placed on the FDA’s import alert list — a fate other drugmakers in India, most notably Ranbaxy, currently face. The generic drug giant late last month saw a fifth facility added to its 2012 consent decree limiting product imports into the U.S.

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